Duns Number:825673239
Device Description: AMSure® Urethral Catheterization TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each 14 Fr. AMSure® Urethral Catheterization TrayCONTENTS STERILIZEDUSING ETHYLENE OXIDE:1 each 14 Fr. Vinyl Catheter1 each 1000 mL Outer Basin Tray1 pair Vinyl Gloves1 each Waterproof Drape1 each Fenestrated Drape1 pack Lubricating Jelly1 each 4 oz Specimen CupNON-STERILE CONTENT:1 pack BZK Swabsticks (3)
Catalog Number
AS870K
Brand Name
AMSure® Urethral Catheterization Tray
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
867ee483-76af-4cf4-9928-a6c31203dc49
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 21, 2018
Package DI Number
40704411007600
Quantity per Package
20
Contains DI Package
10704411007609
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |